MIOZAC 250 mg /20 Ml Infusion Solution

Зміст інструкції

1. MIOZAC 250 mg/ 20 ml solution for intravenous infusion
   1. What is MIOZAC and what is it used for
   2. What you need to know before using MIOZAC
   3. How to use MIOZAC
   4. Possible side effects
   5. How to store MIOZAC
   6. Contents of the pack and other information
2. MIOZAC 250 mg/20 ml solution for intravenous infusion

MIOZAC 250 mg/ 20 ml solution for intravenous infusion

dobutamine hydrochloride

Generic medicine
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What MIOZAC is and what it is used for
• 2. What you need to know before using MIOZAC
• 3. How to use MIOZAC
• 4. Possible side effects
• 5. How to store MIOZAC
• 6. Contents of the pack and other information

1. What is MIOZAC and what is it used for

MIOZAC contains the active substance dobutamine hydrochloride, which belongs to a group of medicines called
catecholamines that work by stimulating heart activity, improving blood flow throughout the body.
MIOZAC is used in emergency situations to improve heart function, when this
is compromised (heart failure), following organ damage (organic heart disease) or surgery.
In people who have an alteration in heart rate (atrial fibrillation), a digitalis medicine must be administered to treat arrhythmias, before the administration of dobutamine
hydrochloride.

2. What you need to know before using MIOZAC

Do not use MIOZAC

• if you are allergic to dobutamine hydrochloride, to other similar substances or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from heart or blood vessel problems of an obstructive type (idiopathic hypertrophic subaortic stenosis);

Warnings and precautions
Consult your doctor or nurse before MIOZAC is administered to you
This medicine must be administered to you with great care and under strict medical supervision in the
following cases:

• if you have heart problems;
• if you are dehydrated (hypovolemia);
• if you are being treated with beta-blockers, used to lower blood pressure;
• if you have low levels of potassium in your blood, as they may decrease further.

The use of this medicine following a heart attack must be carried out with great caution because
it may worsen damage to the heart.
During the administration of MIOZAC, heart parameters (heart rate
and rhythm, infusion rate, ECG, blood pressure, pulmonary capillary pressure and cardiac output) must be continuously monitored.
For athletes: the use of the drug without therapeutic necessity constitutes doping and may
still result in positive doping tests.

Other medicines and MIOZAC
Tell your doctor or nurse if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking the following medicines:

• medicines used for heart problems such as sodium nitroprussiate;

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask
your doctor or nurse for advice before this medicine is administered to you.
This medicine should not be administered during pregnancy unless absolutely necessary.

Driving and operating machinery
No data are available to establish the effect of the medicine on the ability to drive vehicles and operate
machinery.

MIOZAC contains sodium metabisulfite and sodium
This medicine contains sodium metabisulfite, which rarely may cause severe hypersensitivity reactions and
bronchospasm.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How to use MIOZAC

This medicine will be administered to you in hospital by trained healthcare professionals. If you have any doubts, consult your
doctor or nurse.
This medicine is administered by intravenous infusion (into a vein) after appropriate dilution.
The initial dose is 2.5-10 micrograms per kg of body weight per minute through continuous intravenous
infusion. The flow rate and dosage will be adjusted based on your response to therapy.

If you use more MIOZAC than you should
This medicine will be administered by trained personnel, so it is unlikely that you will be
given an excessive dose.
Symptoms of an overdose may include decreased appetite (anorexia), nausea, vomiting, tremor,
anxiety, headache (cephalalgia), difficulty breathing (dyspnea), heart and circulation problems (palpitations,
anginal or nonspecific chest pain, increased blood pressure, altered heartbeat,
myocardial ischemia).
If you experience these symptoms or think that you have been given an excessive amount of this medicine, seek
immediate medical attention from your doctor or nurse.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:

• increase in blood pressure (hypertension) and heart rate (heart frequency);
• changes in heart rhythm (ventricular rhythm disturbances);
• decrease in blood pressure (hypotension);
• nausea;
• headache;
• difficulty breathing (dyspnea);
• non-specific or heart-related chest pain (angina), palpitations;
• inflammation of the veins at the injection site (phlebitis) and tissue damage at the injection site if the medicine leaks from the veins (extravasation) during infusion;
• reduction of potassium levels in the blood (hypokalaemia);

Heart muscle problems (stress cardiomyopathy also known as Takotsubo syndrome) which present with chest pain, shortness of breath, dizziness, fainting, irregular heartbeat when
dobutamine is used for stress echocardiography (frequency not known: the frequency cannot be
defined based on available data).
Secondary effects for prolonged treatments (up to 72 hours) have not been different from those observed in
short-term treatments.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store MIOZAC

Medical and nursing staff are aware of the storage conditions of the medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after “Scad”.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C and protect from light.
After dilution of the vial, the prepared solutions must be used within 24 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatMIOZACcontains

• The active ingredient is dobutamine. Each vial contains 280.28 mg of dobutamine hydrochloride, equivalent to 250 mg of dobutamine.
• The other ingredients (excipients) are: sodium metabisulfite, water for injections.

Description of the appearance of MIOZAC and contents of the pack
Pack of 1 vial of 20 ml solution for intravenous infusion.

Marketing Authorisation Holder and manufacturer
FISIOPHARMA SRL,
Nucleo Industriale - 84020 PALOMONTE (SA) - Italy

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MIOZAC 250 mg/20 ml solution for intravenous infusion

dobutamine hydrochloride

Medically equivalent product
The following information is intended exclusively for physicians or healthcare professionals
CLINICAL INFORMATION
Dosage and method of administration
The infusion rate required to increase cardiac output generally ranges from 2.5 to 10
mcg/Kg/minute.
Rarely, the rate required to achieve the effect may rise to 40 mcg/Kg/minute (see table). The following
infusion rate scheme (ml/kg/min) is reported for concentrations of 250, 500, 1000 mcg/ml.

Administration dosageInfusion rate
250 mcg/ml 500 mcg/ml 1000 mcg/ml
(mcg/kg/min) (ml/kg/min) (ml/kg/min) (ml/kg/min)
2.5 0.01 0.005 0.0025
5.0 0.02 0.010 0.0050
7.5 0.03 0.015 0.0075
10.0 0.04 0.020 0.0100
12.5 0.05 0.025 0.0125
15.0 0.06 0.030 0.0150
The administration rate and duration of therapy should be adjusted based on the patient's response, determined by heart rate, presence of ectopic activity, blood pressure, urine flow, and, when possible, measurement of pulmonary capillary pressure and cardiac output.
In humans, concentrations up to 5000 mcg/ml (250mg/50ml) have been administered.
The total volume of fluids to be administered must be determined based on the patient's fluid and electrolyte requirements.

Reconstitution of the medicinal product
At the time of administration, MIOZAC must be further diluted, in a container for intravenous use, to a final volume of at least 50 ml with one of the following solutions i.v.:
5% Dextrose
5% Dextrose and 0.45% Sodium Chloride
5% Dextrose and Sodium Chloride at

• 0.9% 10% Dextrose Isolyte®M with 5% Dextrose Ringer lactate 5% Dextrose in Ringer lactate Osmitrol® 20% in water 0.9% Sodium Chloride Sodium Lactate Normosol®-M in D5-W

Prepared solutions must be used within 24 hours. Solutions containing MIOZAC solution may take on a pink color, which may increase in intensity over time.
This color change is due to slight oxidation of the drug but, within the recommended administration time, does not result in a significant loss of potency.

Warnings
MIOZAC may cause a marked increase in heart rate or blood pressure.
In clinical studies, approximately 10% of patients experienced heart rate increases of 30 beats/min or more, and approximately 7.5% recorded systolic blood pressure increases of 50 mmHg or more.
Generally, a reduction in dosage decreases or eliminates these effects.

Precautions for use

• 1 -During the administration of MIOZAC solution, as with any other adrenergic agent, ECG and blood pressure should be continuously monitored. In addition, whenever possible and for the purpose of safe and effective infusion of MIOZAC solution, pulmonary capillary pressure and cardiac output should be monitored.
• 2 -Hypovolemia should be adequately corrected before initiating treatment with MIOZAC solution.
• 3 -Animal studies indicate that MIOZAC solution may be ineffective if beta-blockers have been administered recently. In this case, peripheral vascular resistance may increase.
• 4 -No improvement may be observed in the presence of a marked mechanical obstruction, such as severe aortic valve stenosis.
• 5 -Dobutamine, like other ß - agonists, may cause a modest reduction in serum potassium without reaching, if rarely, levels of hypokalemia. Therefore, monitoring of potassium levels is recommended during therapy with MIOZAC solution

Use after acute myocardial infarction
Clinical experience with MIOZAC solution after acute myocardial infarction is insufficient to establish the
safety of the drug for this use.
It is known that any pharmacological agent capable of increasing the heart's contractile force and its frequency
may cause an increase in the infarcted area, but it is not known whether this may also occur with
Dobutamine.

Overdosage
Cases of Dobutamine overdose have been reported rarely.
The initial action consists of stopping the administration of dobutamine, establishing airway patency, and ensuring oxygenation and ventilation. Promptly implement resuscitation measures.
Severe ventricular tachycardia can be successfully treated with propanolol or lidocaine. Hypertension generally responds to dose reduction or discontinuation of therapy.
If necessary, carefully monitor and maintain vital signs, blood gases, serum electrolytes, etc. within acceptable limits. Absorption of drugs from the gastrointestinal tract can be reduced by activated charcoal, which is often more effective than inducing vomiting or gastric lavage. Therefore, consider administering activated charcoal in addition to or instead of gastric lavage. Repeated administration of charcoal may accelerate the elimination of some previously taken drugs.
When performing gastric emptying or activated charcoal administration maneuvers, ensure the integrity of the respiratory tract.
Forced diuresis, peritoneal dialysis, hemodialysis, and charcoal hemoperfusion have not been shown to be beneficial in cases of dobutamine overdose.

Incompatibilities
Do not dilute MIOZAC with 5% sodium bicarbonate or other strongly alkaline solutions. MIOZAC should not be used together with other substances containing sodium metabisulfite and ethanol.

For further information, consult the Summary of Product Characteristics.